Retrograde Intrarenal Stone Surgery - A Method of Treating the ESWL Resistant Kidney Stone - Tabular View

Tracking Information

First Received Date ^ICMJE

May 8, 2006

Last Updated Date

January 29, 2007

Start Date ^ICMJE

June 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Renal pelvic pressure

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00323843 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Blood pressure
Pulse

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Retrograde Intrarenal Stone Surgery - A Method of Treating the ESWL Resistant Kidney Stone

Official Title ^ICMJE

RIRS - A Method of Treating the ESWL Resistant Kidney Stone

Brief Summary

Is it possible to decrease the intrarenal pressure in the kidney during endoscopic management of kidney stone by topical administration of drugs? In order to secure fewer complications in ureteroscopic operations the pharmacological agent isoproterenol is tested on pigs and human to determine its potential of lowering intrarenal pressure.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Kidney Stone
Ureteroscopy

Intervention ^ICMJE

Drug: Isoproterenol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

February 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Indication for RIRS procedure
Age > 18 years
Normotensive
Capable of understanding information given

Exclusion Criteria:

Previous myocardiac infarct
Daily use of alpha- og beta- blocking medicine og calcium antagonists
Use of NSAID the last 2 days
Stone in the ureter
Declared
Known malignant disease in urinary tract
Bladder disease
Nephrostomies inserted
JJ-catheters inserted
Prisoners
Pregnant
Nursing mothers

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00323843

Responsible Party

Study ID Numbers ^ICMJE

2005-005972-34

Study Sponsor ^ICMJE

Fredericia Hosptial

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Helene U Jung

Fredericia Hospital, Dpt. of Urology

Information Provided By

Fredericia Hosptial

Verification Date

January 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP